THERASPHERE Y-90 Glass Microspheres ™


The Only FDA Approved Y-90 Therapy for HCC


After 20 years as a humanitarian After 20 yea tion


exemption device (HDE), the FDA has granted


has granted TheraSphere pre-market approval, m


approval, making TheraSphere the only Y 90 th


longer r quired by the FDA.


only Y-90 therapy indicated for HCC. This means (IRB) approv


e is no


This means institutional review board (IRB) approval of TheraSphere longer required by the FDA.


TheraSphere™


Yttrium-90 Glass Microspheres


INDICATION FOR USE: TheraSphere is indicated for use as selective internal radiation therapy (SIRT) for local tumor control of solitary tumors (1-8 cm in diameter), in patients with unresectable hepatocellular carcinoma (HCC), Child- Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status. CONTRAINDICATIONS: TheraSphere is contraindicated in patients: whose Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques • who show shunting of blood to the lungs that could result in delivery of greater than 16.5 mCi (0.61 GBq) of Y-90 to the lungs. Radiation pneumonitis has been seen rarely in patients receiving doses to the lungs greater than 30 Gy in a single treatment. • in whom hepatic artery catheterization is contraindicated,   which may make the patient a poor candidate for locoregional radiation treatment. • who are pregnant. WARNINGS:   open the dose vial acrylic shield prior to patient treatment. Post-treatment, waste materials require caution to prevent contamination and beta shielding due to residual glass microspheres. PRECAUTIONS:        to others below regulated limits. • Release instructions: The patient should follow good hygiene (e.g., proper hand washing). Caregivers, family, and others do not require restrictions on patient contact; however, they can minimize their radiation exposure by avoiding prolonged time (>12 hours per day)   liver tissue handling: Special liver tissue handling may be required for post-treatment surgery, explant, or transplant since the glass microspheres remain permanently implanted in the liver tissue. Disclosure of the treatment will be required if cremation is considered. POTENTIAL ADVERSE EVENTS: The use  on clinical trial data, literature reviews and post market surveillance, adverse events potentially associated with treatment using Y-90 microspheres, including TheraSphere, may include the following: Allergic reaction • Altered liver function, acute or chronic • Anorexia • Anxiety • Ascites • Bile Duct injury •  ulcer or ulceration • Hepatic encephalopathy • Hepatorenal failure • Hiccups • Hypertension • Hypotension • Infection (any location) • Liver failure, acute or chronic • Lymphopenia • Malaise • Mood alteration • Muscle weakness • Nausea • Neutropenia • Pain (any location) • Pancreatitis • Platelet count   bleeding/hematoma at site • Constipation/abdominal distension • Fatigue • Flushing • Infection • Nausea • Nerve damage. CAUTION: Federal (USA) law restricts this device to sale by or on order of a physician. PI-992004-AA. Note: Dose to the liver does not exceed 150 Gy. The physician should always take  


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